E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission (CDAI < 150) at Week 4 and endoscopic response defined as decrease in SES-CD > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12, in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration at Baseline. |
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E.2.2 | Secondary objectives of the trial |
• To assess the efficacy and safety of two adalimumab induction regimens in reducing signs and symptoms of Crohn's disease at Week 12. • To assess the efficacy and safety of two adalimumab maintenance regimens in reducing signs and symptoms of Crohn's disease at Week 56. • To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subject is between the ages of 18 to 75 years • Diagnosis of colonic, ileocolonic, or ileal Crohn's disease for ≥ 3 months prior to Baseline and confirmed by endoscopy during the Screening period or endoscopy performed within 45 days before Baseline. • Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 at Baseline despite concurrent or prior treatment with a full oral corticosteroids and/or immunosuppressants
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E.4 | Principal exclusion criteria |
• Subject with ulcerative colitis or indeterminate colitis • Subject who has had surgical bowel resections within the past 6 months or is planning resection • Subject with an ostomy or ileoanal pouch • Subject with bowel stricture or abdominal or peri-anal abscess • Subject who has short bowel syndrome • Chronic recurring infections or active TB |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who achieve clinical remission at Week 4 and proportion of subjects with endoscopic response (decrease > 50% SES-CD from Baseline [or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline]) at Week 12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Proportion of subjects with clinical remission at weeks 4 and 12 • Proportion of subjects with CDAI < 150 at Week 4 and endoscopic response at Week 12 • Proportion of subjects with clinical remission at week 12 • Among subjects on corticosteroids at baseline, proportion of subjects who discontinued corticosteroid use and achieved clinical remission at week 12 • Proportion of subjects with endoscopic remission (SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable) at Week 12 • Change from Baseline in fecal calprotectin level at Week 4. • Proportion of subjects with hs-CRP < 5 mg/L and fecal calprotectin < 250 μg/g at Week 4. • Proportion of subjects with CDAI < 150, hs-CRP < 5 mg/L, and fecal calprotectin < 250 μg/g at Week 4. • Proportion of subjects with CDAI < 150, hs-CRP < 5 mg/L, SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, and fecal calprotectin < 250 μg/g at Week 12. • Proportion of subjects who achieve an SES-CED ≤ 2 at Week 12. • Proportion of subjects with clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 4. • Proportion of subjects with clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 12. • Proportion of subjects achieving response in IBDQ Bowel Symptom domain (increase of IBDQ bowel symptom domain score ≥ 8) at Week 4. • Proportion of subjects achieving response in IBDQ Bowel Symptom domain (increase of IBDQ bowel symptom domain score ≥ 8) at Week 12. • Proportion of subjects achieving response in IBDQ fatigue item (increase of IBDQ fatigue item score ≥ 1) at Week 12. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4 and 12 depending on the endpoints |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
two adalimumab induction and maintenance regimens are compared |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
European Union |
Israel |
Switzerland |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date of the Last subject last visit, or the last follow-up contact, whichever is longer. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |